San Diego, CA (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm (HK:2181) filed recently a New Drug Application for the Infliximab biosimilar antibody in China. Sorrento plans to file a Biologics License Application (BLA) for the Infliximab biobetter antibody in the United States in 2020.
Infliximab (currently commercialized under the trade name Remicade® - trademark of Janssen) is an injectable monoclonal antibody prescription drug that's used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis (a type of spinal arthritis), psoriatic arthritis, and the red, scaly skin patches of plaque psoriasis. Usually prescribed when other medicines or treatments have failed, infliximab belongs to a class of drugs called tumor necrosis factor inhibitors (TNFs), which work by suppressing the action of a protein called TNF, which has been tied to inflammation.
Sorrento, through a global licensing agreement with Mabpharm, owns the global rights to the Mabpharm Infliximab biobetter antibody outside of China. Mabpharm recently submitted a new drug application with the National Medical Products Administration (the NMPA) for a recombinant anti-TNF-alpha chimeric monoclonal antibody based on infliximab. This variant uses CHO expression system, resulting in a potentially better safety profile and lower immunogenicity when compared to the currently marketed competitive drugs.
Sorrento is planning to file all the required document for a Biologics License Application (BLA) by the end of 2020.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T” and “DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido®. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients and osteoarthritis. ZTlido was approved by US FDA on 02/28/18.
For more information visit www.sorrentotherapeutics.com
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward looking statements include statements regarding the developments of and prospects for the Infliximab biobetter antibody ; Sorrento's products and technologies, including its antibody products and technologies; timing Sorrento’s ability to file a BLA for the Infliximab biobetter antibody in the United States , Sorrento's ability to leverage the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its strategies; outcome of the data from a clinical trial for Infliximab biobetter antibody); Sorrento's M&A and licensing strategy; and Sorrento's and its partners’ ability to accelerate the development of any lead programs in the clinic.. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's, its subsidiaries' and partners’ technologies and prospects; risks that Biologics License Application (BLA) for the Infliximab biobetter antibody in the United States may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido® and G-MAB™ are trademarks owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Sorrento and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
All other trademarks are the property of their respective owners.
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